Left atrial appendage occlusion device

ABSTRACT

An exemplary occlusion device is disclosed. In various embodiments, the exemplary occlusion device includes a cap chamber and a bulb chamber for occluding a left atrial appendage (LAA). In particular embodiments, after delivery to the LAA, the cap chamber and the bulb chamber are each inflated via various amounts of fluid(s) to occlude the LAA.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of, and claims priority to, U.S. patentapplication Ser. No. 15/306,611, filed Oct. 25, 2016, entitled “LeftAtrial Appendage Occlusion Device,” which claims the benefit of andpriority under 35 U.S.C. § 371 to International Patent Application No.PCT/US15/27666, filed Apr. 24, 2015, entitled “Left Atrial AppendageOcclusion Device,” which claims priority to U.S. Provisional PatentApplication No. 61/984,342, filed Apr. 25, 2014, entitled, “Left AtrialAppendage Occlusion Device” each of which are incorporated herein byreference in their entireties.

TECHNICAL FIELD

The present disclosure relates generally to medical devices.

BACKGROUND

The left atrial appendage (LAA) originates from the left wall of theleft atrium. This fingerlike projection opens to the atrium through anovoid orifice and extends 2-4 cm long, pointing towards the apex.

Atrial fibrillation (AF) is the most common arrhythmia (i.e. irregularlytimed contraction) and oftentimes occurs due to sustained increased leftatrial afterload—leading to an enlargement of the left atrium (LA). Thepresence of AF may establish a positive feedback loop that furthersenlargement and increases the probability of thrombus (i.e. clotting)formation. As the LAA is not contracting on time, blood stasis occurs inthe appendage as the blood flows into the appendage but does not flowout in a rhythmic fashion. This leads to blood clotting in theappendage, which then becomes a risk as the irregular contraction of theLAA may force the clot to travel out of the appendage and into thebrain, leading to an ischemic stroke.

It is believed by researchers that up to 90 percent of the clots foundin the brain come from the LAA. If AF patients are not treated, theirrisk of stroke increases as they age; 15 percent of all strokes arecaused by AF. However, in patients 70 years and older, more than 20 to25 percent of strokes are caused by atrial fibrillation.

Current research suggests that occlusion of the left atrial appendagereduces the risk of ischemic stroke in atrial fibrillation patients bypreventing LAA thrombus formation from occurring. It also acts as analternative therapy to oral anticoagulation (OAC). Some patients electto not take OACs or are ineligible due to side effects.

BRIEF SUMMARY OF THE DISCLOSURE

According to particular embodiments, the present disclosure includes anocclusion device for occluding a left atrial appendage, the deviceincluding: A) a connection system configured for attaching an occlusiondevice to a fluid transport device; and B) an inflatable balloonoperatively fastened to the connection system, the inflatable balloonincluding a cap chamber and a bulb chamber, the cap chamber and the bulbchamber separated by an elastomeric wall, wherein: 1) the connectionsystem a) extends through the cap chamber and at least partially throughthe bulb chamber, b) is configured for delivering one or more fluids tothe cap chamber and the bulb chamber, and c) includes one or morevalues; 2) the cap chamber is substantially disc-shaped and isconfigured to expand outwardly in a lateral direction from a center ofthe cap chamber to substantially fill a first portion of a left atrialappendage; and 3) the bulb chamber is configured to expand outwardly tosubstantially fill a second portion of the left atrial appendage.

In various embodiments, a device, the device including: A) a connectionsystem configured for attaching the device to a fluid transport device,the connection system extending at least partially through each of a capchamber and a bulb chamber of an inflatable balloon and is configuredfor delivering one or more fluids to the cap chamber and the bulbchamber; and B) the inflatable balloon, wherein the inflatable balloonis operatively connected to the connection system and includes: 1) thecap chamber, wherein the cap chamber is configured to expand outwardlyin a lateral direction from a center of the cap chamber; and 2) the bulbchamber, wherein the bulb chamber is separated from the cap chamber byan elastomeric wall and is configured to expand outwardly tosubstantially fill a void.

In one or more embodiments, a method for occluding a left atrialappendage, the method including providing an occlusion device includinga connection system operatively connected to a balloon system, wherein:A) the connection system fluidly connects a first chamber and secondchamber of the balloon system via at least one valve; B) the balloonsystem is configured to be: 1) passed through a catheter system; 2) atleast partially inflated such that a first chamber of the balloon systemexpands in a lateral direction for substantially filling a first portionof a left atrial appendage of a patient; and 3) inflated such that asecond chamber of the balloon system expands for substantially filling asecond portion of the left atrial appendage of the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and benefits of the present disclosure will be apparentfrom a detailed description of various embodiments thereof taken inconjunction with the following drawings, wherein similar elements arereferred to with similar reference numbers, and wherein:

FIG. 1 is a side view of an exemplary occlusion device in asubstantially uninflated state, according to one embodiment of thepresent disclosure;

FIG. 2 is a partial cross-sectional view of the exemplary occlusiondevice in the substantially uninflated state of FIG. 1, according to oneembodiment of the present disclosure;

FIG. 3 is a side view of an alternate exemplary occlusion device in asubstantially uninflated state according to one embodiment of thepresent disclosure;

FIG. 4 is a partial cross-sectional view of the alternate exemplaryocclusion device in the substantially uninflated state of FIG. 3,according to one embodiment of the present disclosure;

FIG. 5 is a perspective view of a portion of an exemplary connectionsystem of the exemplary occlusion device of FIG. 1, according to oneembodiment of the present disclosure;

FIG. 6 is a perspective view of a portion of an exemplary connectionsystem of the exemplary occlusion device of FIG. 2, according to oneembodiment of the present disclosure;

FIG. 7 is a top view of an exemplary fluid ring of the exemplaryocclusion device of FIG. 1, according to the one embodiment of thepresent disclosure;

FIG. 8 is a partial cross-sectional view of the exemplary occlusiondevice of FIG. 1, according to one embodiment of the present disclosure;

FIG. 9 is side view of an exemplary occlusion device in a partiallyinflated state in an exemplary left arterial atrium environment,according to one embodiment of the present disclosure;

FIG. 10 is a partial cross-sectional view of the partially inflatedexemplary occlusion device of FIG. 9, according to one embodiment of thepresent disclosure;

FIG. 11 is side view of an exemplary occlusion device in an inflatedstate in an exemplary left arterial atrium environment, according to oneembodiment of the present disclosure; and

FIG. 12 is a partial cross-sectional view of the inflated exemplaryocclusion device of FIG. 11, according to one embodiment of the presentdisclosure.

DETAILED DESCRIPTION

Whether or not a term is capitalized is not considered definitive orlimiting of the meaning of a term. As used in this document, acapitalized term shall have the same meaning as an uncapitalized term,unless the context of the usage specifically indicates that a morerestrictive meaning for the capitalized term is intended. However, thecapitalization or lack thereof within the remainder of this document isnot intended to be necessarily limiting unless the context clearlyindicates that such limitation is intended.

For the purpose of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the figures and specific language will be used todescribe the same. It will, nevertheless, be understood that nolimitation of the scope of the disclosure is thereby intended; anyalterations and further modifications of the described or illustratedembodiments, and any further applications of the principles of thedisclosure as illustrated therein are contemplated as would normallyoccur to one skilled in the art to which the disclosure relates. Alllimitations of scope should be determined in accordance with and asexpressed in the claims.

Overview

The present disclosure relates generally, according to particularembodiments, to an implantable, inflatable device including softpolymeric material(s), one-way sealing system, multiple layers, andinsertable fluid for inflation. In various embodiments, the presentdisclosure relates to an implantable, inflatable device for soft tissueclosures such as left atrial appendages. Various embodiments of thedevice disclosed herein may be customizable with a high number ofusability cases, have a low risk of perforation, have a low risk ofbleeding, be deployed through typical transseptal procedure, be used inlieu of anticoagulants or for patients who cannot take anticoagulants,promote immediate occlusion, and not heavily rely on endothelialization.

An exemplary occlusion device includes a connection system, cap chamber,and a bulb chamber. In particular embodiments, the connection systemconsists of a secure attachment method for interaction between thedevice and delivery system. In various embodiments, fluid transport andpassage channels lie within the connection system to facilitate fluiddelivery. In some embodiments, valves are also featured within theconnection system to control fluid flow and to separate the multiplechambers of the device. As further discussed below, in at least oneembodiment, the cap chamber consists of fluid passage channels and afluid ring to allow for the cap chamber to expand laterally from thefluid transport channel.

In particular embodiments, the bulb chamber and cap chamber aremanufactured out of soft polymeric material(s) and are separated by anelastomeric wall and valve(s). In various embodiments, a bulb chamberconsists of a textured surface, interior chamber, and second interiorchamber. The textured surface of the bulb chamber may provide a mannerto interact with the LAA, and the interior chamber(s) may allow for amethod of inflating the bulb chamber to provide anchoring and stabilitywithin the LAA.

The present disclosure depicts an exemplary device as used within a leftatrial appendage within a patient's heart, although it will beunderstood by one of ordinary skill in the art that exemplary deviceembodiments discussed herein may be used in a variety of ways and shouldnot be limited to uses within a patient's heart. In a particularembodiment, an exemplary device may be used to occlude the LAA to helpprevent a stroke in the patient. In this particular embodiment, aclosure procedure may be done under standard transcatheterization andtransseptal techniques using transesophageal echocardiogram (TEE) andcontrast fluoroscopy (fluoro). Continuing with this particularembodiment, after the delivery system is directed to the LAA, theocclusion device is deployed. The device, in this particular embodiment,contains various inflation states ranging from partial to full inflationbased on the amount of fluid inserted into the device using the fluiddelivery system. As will be understood by one of ordinary skill in theart, in this particular embodiment, once all chambers are inflated toadapt to the surrounding LAA anatomy and provide occlusion to preventblood flow from entering the LAA, full inflation has been reached.Continuing with this particular embodiment, the device is detached fromthe delivery system and remains in the LAA and the delivery system isremoved from the body.

Exemplary Device Structure

Turning now to the figures, in the embodiment shown in FIG. 1, anexemplary occlusion device 10 includes: 1) a connection system 20; and2) an inflatable balloon including a cap chamber 40 and a bulb chamber60. In various embodiments, the connection system 20 is operativelyconnected to the cap chamber 40 and the bulb chamber 60 by a suitablefastener, such as, for example, an adhesive (e.g., fibrin glue, tissuesealants, hydrogels, tissue glues, etc.). In one or more embodiments,the connection system 20 is operatively connected to the cap chamber 40and the bulb chamber 60 by a helical thread, which may be constructed ofmetal material(s) (e.g., aluminum, nitinol, stainless steel, etc.), atwist lock method, which may be constructed of metal material(s) (e.g.,aluminum, nitinol, stainless steel, etc.) or polymeric material(s), or aluer lock method, which may be constructed of metal material(s) (e.g.,aluminum, nitinol, stainless steel, etc.) or polymeric material(s).

Turning now to FIG. 2, a partial cross-section of the exemplaryocclusion device of FIG. 1 is shown. In the embodiment shown in FIG. 2,the connection system 20 includes a fluid passage body 22, one or morefluid passage channels 24, a first valve 26, a second valve 28, innerfluid passage channel 30, and an inner fluid passage opening 32. As willbe understood by one of ordinary skill in the art, connection system 20allows an exemplary occlusion device 10, in embodiments that include ahelical thread or twist lock (and other embodiments), to securely attachto a device delivery system. As will be further discussed herein, invarious embodiments, fluid is inserted into the exemplary occlusiondevice 10 through connection system 20 and dispersed through one or morefluid passages through a fluid ring 44 in order to expand a cap chamber40.

In particular embodiments, the fluid passage body 22, which may beconstructed of polymeric material(s) (e.g., polyurethane, silicone,latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), is in a particular embodiment, fastened by awelding technique to the connection system 20 and the cap chamber 40. Inone embodiment, the fluid passage body 22 is a body that facilitates thetransport of fluid to the fluid ring 44 and into the bulb chamber 60.

In various embodiments, the fluid passage channel 24 is made frompolymeric material(s) (e.g., polyurethane, silicone, latex,polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.) and is found within the cap body 42. In atleast one embodiment, the fluid passage channel 24 is attached to fluidpassage body 22 by a welding technique. In various embodiments, thefluid passage channel 24 contains one or more channels, which can bestraight cylindrical shape, curved cylindrical shape, etc., to deliverfluid to the fluid ring 44.

In some embodiments, the valve 26, which may be constructed of polymericmaterial(s) (e.g., polyurethane, silicone, latex, polyurethanes,silicones, latex, nylons, Pebax, PET, PE and other polyolefines, PVC,etc.), is found fastened through methods such as, but not limited to,adhesives, molding, welding, and etc. to the elastomeric wall 46 and theinner fluid passage channel 30 at the proximal end of fluid passage body22 and is configured to control fluid insertion into bulb chamber 60. Invarious embodiments, the valve 26 is a one-way valve. In one or moreembodiments, the valve 26 is a check valve. In some embodiments, thevalve 26 is any other suitable type of valve, such as, for example,duckbill valve, umbrella valve, or Belleville valve.

According to particular embodiments, the valve 28, which may be madefrom polymeric material(s) (e.g., polyurethane, silicone, latex,polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), is fastened to the inner fluid passage channel30 and the interior chamber 64 through methods such as, but not limitedto, adhesives, molding, welding, and etc. and is configured to controlthe transport of fluid into interior chamber 64. In various embodiments,the valve 28 is a one-way valve. In one or more embodiments, the valve28 is a check valve. In some embodiments, the valve 28 is any othersuitable type of valve, such as, for example, duckbill valve, umbrellavalve, and Belleville valve.

The inner fluid passage channel 30, which may be made of polymericmaterial(s) (e.g., polyurethane, silicone, latex, polyurethanes,silicones, latex, nylons, Pebax, PET, PE and other polyolefines, PVC,etc.), is, in some embodiments, fastened between the elastomeric wall 46and the interior chamber 64 through methods such as, but not limited to,adhesives, molding, welding, and etc. and allows controlled fluidtransport between the valve 26 and the valve 28 and into second innerchamber 66 through the inner fluid passage opening 32.

In one embodiment, the inner fluid passage opening 32 may include one ormore openings that allow fluid transport into the second inner chamber66. In some embodiments, these openings may be in elliptical, ovular,circular, slot, etc. shapes.

Continuing with FIG. 2, in the embodiment shown, the inflatable balloonincludes the cap chamber 40. The cap chamber 40, in the embodiment shownin FIG. 2, includes the cap body 42, the fluid ring 44, and theelastomeric wall 46. In particular embodiments, the cap chamber 40laterally expands through the inflation of fluid ring 44 to provideocclusion at a first portion of a left atrial appendage.

In various embodiments, the cap body 42, which may be made of polymericmaterial(s) (e.g., polyurethane, silicone, latex, polyurethanes,silicones, latex, nylons, Pebax, PET, PE and other polyolefines, PVC,etc.), is the main source of support for the cap chamber 40 and is foundsurrounding fluid ring 44 and proximal to the elastomeric wall 46.

In various embodiments, the fluid ring 44, which may be made ofpolymeric material(s) (e.g., polyurethane, silicone, latex,polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), will inflate through an increased presence offluid facilitated by transport from the one or more fluid passagechannels 24 throughout the cap body 42 to enable the lateral expansionof the cap chamber 40.

In particular embodiments, the elastomeric wall 46 is a barrier, whichmay be made of polymeric material(s) (e.g., polyurethane, silicone,latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), to separate the distal cap chamber 40 from theproximal bulb chamber 60. In particular embodiments, the elastomericwall 46 provides support and rigidity as there is an increase of lateralexpansion of the cap chamber 40.

In various embodiments, the elastomeric wall 46 is constructedconcurrently and an integral part with the cap chamber 40 and bulbchamber 60 through molding techniques. In some embodiments, the wall maybe constructed by welding techniques or adhesives with either the capchamber 40 or bulb chamber 60.

In the embodiment shown in FIG. 2, the inflatable balloon furtherincludes the bulb chamber 60. The bulb chamber 60, in particularembodiments, includes an outer textured surface 62, an interior chamber64, and a second interior chamber 66. The bulb chamber 60 will beinflated in order to reinforce occlusion of a left atrial appendage(LAA) and provide anchoring and stability of the embodiment shown inFIG. 2 inside a LAA.

According to at least one embodiment, the outer textured surface 62,which may be constructed of polymeric material(s) (e.g., polyurethane,silicone, latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PEand other polyolefines, PVC, etc.), is found on the exterior of the bulbchamber 60 and can provide interaction between the bulb chamber 60 and aleft atrial appendage. In one embodiment, an outer textured surface 62can be shaped as ridges. In some embodiments, an outer textured surface62 is an integral part of the bulb chamber 60 and can be patterned orprotruding outwards from the bulb chamber 60, at various angles. Invarious embodiments, outer textured surface 62 is applied on the bulbchamber 60 through a microfabrication technique. In some embodiments, anouter textured surface 62 with angles can be formed through moldingtechniques or by coating with unvulcanized or partially vulcanizedelastomeric polymer (e.g. silicone, latex, polyurethane, etc.) that iscured within a shell with a desired inner morphology. In someembodiments, an outer textured surface 62 may be constructed by a fabricoverlay used to form texture while the polymer cures.

In particular embodiments, the interior chamber 64, which may beconstructed of polymeric material(s) (e.g., polyurethane, silicone,latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), is located inside the bulb chamber 60 andfastened to the inner fluid passage channel 30 through methods such as,but not limited to, adhesives, molding, welding, and etc. and willinflate through an increasing presence of fluid through valve 28 andwill enable expansion of bulb chamber 60.

In one or more embodiments, the second interior chamber 66, which may beconstructed of polymeric material(s) (e.g., polyurethane, silicone,latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), will inflate through an increasing presence offluid and is present in order to fine tune an exemplary occlusion device10 (as further discussed below).

A second exemplary occlusion device 200 is depicted in FIGS. 3 and 4. Inthe embodiments shown in FIGS. 3 and 4, the exemplary occlusion device200 includes a secure attachment system 220, fluid passage channel 222,valve 224, fluid passage channel opening 226, valve 228, cap chamber240, interior cap chamber 242, elastomeric wall 246, bulb chamber 260,textured surface 262, and inner bulb chamber 264.

In one embodiment, the secure attachment system 220, which may beconstructed of polymeric material(s) (e.g., polyurethane, silicone,latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.) or metal material(s) (e.g., aluminum, nitinol,stainless steel, etc.), may be a twist lock that will fasten anexemplary occlusion device 200 to a delivery system through methods suchas, but not limited to, adhesives, molding, welding, and etc. and isfound at the surface and proximal end of an exemplary occlusion device200.

In various embodiments, the fluid passage channel 222, which may beconstructed of a polymeric material(s) (e.g., polyurethane, silicone,latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), is fastened through methods such as, but notlimited to, adhesives, molding, welding, and etc. inside the cap chamber240 and to an elastomeric wall 246, and will allow the transport offluid to cap chamber 240 and bulb chamber 260.

According to particular embodiments, the valve 224, which may beconstructed of polymeric material(s) (e.g., polyurethane, silicone,latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), is operatively fastened through methods suchas, but not limited to, adhesives, molding, welding, and etc. to thesecure attachment system 220 and will control the transport of fluidinto and out of the fluid passage channel 222. In various embodiments,the valve 224 is a one-way valve. In one or more embodiments, the valve224 is a check valve. In some embodiments, the valve 224 is any othersuitable type of valve, such as, for example, duckbill valve, umbrellavalve, and Belleville valve.

In various embodiments, the fluid passage channel opening 226 isgenerally circular in shape and is configured to allow the transport offluid from the fluid passage channel 222 to the cap chamber 240. In someembodiments, the fluid passage channel opening 226 may be an elliptical,ovular, etc. shape. In one or more embodiments, the fluid passagechannel opening 226 contains a one-way valve, which may be constructedof polymeric material(s) (e.g., polyurethane, silicone, latex,polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.). In at least one embodiment, this valve may bea check valve. In some embodiments, the valve may be any other suitabletype of valve, such as, for example, duckbill valve, umbrella valve, andBelleville valve.

In some embodiments, the valve 228, which may be constructed ofpolymeric material(s) (e.g., polyurethane, silicone, latex,polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), is operatively fastened through methods suchas, but not limited to, adhesives, molding, welding, and etc. to theelastomeric wall 246 and is configured to control the transport of fluidfrom the fluid passage channel 222 to the bulb chamber 260.

In various embodiments, the valve 228 is a one-way valve. In one or moreembodiments, the valve 228 is a check valve. In some embodiments, thevalve 228 is any other suitable type of valve, such as, for example,duckbill valve, umbrella valve, and Belleville valve.

In at least one embodiment, the cap chamber 240, which may beconstructed of polymeric material(s) (e.g., polyurethane, silicone,latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), is found at a proximal end of the exemplarydevice 200, the elastomeric wall 246, and the bulb chamber 260 and willexpand in size as an interior cap chamber 242 is inflated with fluid.

In one embodiment, the interior cap chamber 242, found inside capchamber 240, is configured to laterally expand due to an increasingpresence of fluid transported through a fluid passage channel 222 andfluid passage channel opening 226.

In particular embodiments, the elastomeric wall 246, which may beconstructed of polymeric material(s) (e.g., polyurethane, silicone,latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), is located between the cap chamber 240 and theinner bulb chamber 264. The elastomeric wall 246 is configured to expandas fluid is transported in inner cap chamber 242 and inner bulb chamber264.

In one embodiment, the bulb chamber 260, which may be constructed ofpolymeric material(s) (e.g., polyurethane, silicone, latex,polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), is located at the distal end of the exemplarydevice 200 and includes surface texture 262 and the inner bulb chamber264. In particular embodiments, the bulb chamber 260 will expand in sizeas the inner bulb chamber 264 is inflated with fluid.

In various embodiments, surface texture 262 is a ribbed pattern found onbulb chamber 260 and is configured to provide attachment of theexemplary device 200 to a left atrial appendage. In some embodiments,the surface texture 262 cis an angled pattern, checkered pattern, etc.

In one embodiment, the inner chamber 264, found inside bulb chamber 260and at a distal end of the exemplary device 200, the cap chamber 240,and the elastomeric wall 246, is configured to be inflated through anincreasing presence of fluid through a fluid passage channel 222.

FIGS. 5 and 6 depict portions of exemplary connection systems 20 and220. In the embodiment shown in FIG. 5, connection system 20 includes anattachment method 22, a fluid delivery method 26, and an operativefastener 28.

In one embodiment, the attachment method 22, which can be made of metalmaterial(s), is found at a proximal end of an exemplary connection 20and can be a helical thread configured to allow secure attachment of anexemplary left atrial appendage device to a device delivery system.

In one embodiment, the fluid delivery method 26, which may be made ofpolymeric material(s) (e.g., polyurethane, silicone, latex,polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.) or metal material(s) (e.g. nitinol, stainlesssteel, aluminum, etc.), is located inside exemplary connection 20 andwill allow attachment of a fluid delivery method from a delivery system.

In one embodiment, the operative fastener 28, which may be constructedof metal material(s) or polymeric material(s) (e.g., polyurethane,silicone, latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PEand other polyolefines, PVC, etc.), is located at a distal end of theexemplary connection 20 and is configured to be fastened to an exemplaryocclusion device 10 through methods such as, but not limited to,adhesives, welding, and etc.

In the embodiment shown in FIG. 5, the connection system 220 includes anattachment method 224. In one embodiment, the attachment method 224 is atwist lock, which may be constructed of polymeric material(s) (e.g.,polyurethane, silicone, latex, polyurethanes, silicones, latex, nylons,Pebax, PET, PE and other polyolefines, PVC, etc.) or metal material(s)(e.g., aluminum, nitinol, stainless steel, etc.), and is configured toallow secure attachment of the exemplary occlusion device 200 to adevice delivery system.

FIG. 7 shows an exemplary fluid ring 44. In the embodiment shown, thefluid ring 44 includes an outer fluid ring channel 48 and an inner ringtransport channel 50.

In one or more embodiments, the outer fluid ring channel 48, which maybe constructed of polymeric material(s) (e.g., polyurethane, silicone,latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), may be circular shaped, ovular shaped,elliptical shaped, etc. and inflated through a transport of fluidthrough the inner ring transport channel 50.

In various embodiments, the inner transport channel 50, which may beconstructed of polymeric material(s) (e.g., polyurethane, silicone,latex, polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), is a substantially straight channel configuredto deliver fluid to the outer fluid ring channel 48 for the purposes ofinflating the exemplary fluid ring 44.

It will be understood by one of ordinary skill in the art that the fluidring 44 is one exemplary embodiment of a mechanism for inflating the cap42. In particular embodiments, other mechanisms may be incorporated intoan occlusion device, such as, for example an inner cap chamber that canlaterally expand by an increase presence of fluid in order to provideocclusion at a first portion of a left atrial appendage.

FIG. 8 shows a partial cross-section of the exemplary occlusion device10. In particular, FIG. 8 shows the one or more fluid passage channels24, the valve 26, and the cap body 42.

In various embodiments, the fluid passage channel 24 contains one ormore channels, which may be constructed of polymeric material(s) (e.g.,polyurethane, silicone, latex, polyurethanes, silicones, latex, nylons,Pebax, PET, PE and other polyolefines, PVC, etc.), configured to deliverfluid through an opening (which may be a circular, elliptical, or ovularshape, and defined by fluid passage body 22) to an exemplary fluid ring44.

In some embodiments, the valve 26, which may be constructed of polymericmaterial(s) (e.g., polyurethane, silicone, latex, polyurethanes,silicones, latex, nylons, Pebax, PET, PE and other polyolefines, PVC,etc.), is located at the proximal end of the fluid passage body 22 andis configured to allow fluid insertion into the bulb chamber 60. Invarious embodiments, the valve 26 is a one-way valve. In one or moreembodiments, the valve 26 is a check valve. In some embodiments, thevalve 26 is any other suitable type of valve, such as, for example,duckbill valve, umbrella valve, and Belleville valve.

In one embodiment, the cap body 42, which may be constructed ofpolymeric material(s) (e.g., polyurethane, silicone, latex,polyurethanes, silicones, latex, nylons, Pebax, PET, PE and otherpolyolefines, PVC, etc.), surrounds fluid passage body 22 and exemplaryfluid ring 44 and provides structure and support for cap body 40 and anexemplary fluid ring 44. In some embodiments, the cap body 42 isconstructed through thermal welding or molding techniques. In otherembodiments, the cap body 42 can be an integral structure of the capchamber.

As will be understood from the present disclosure, the exemplary devicesdescribed herein may be used in any suitable way. In particularembodiments, the exemplary devices described herein may be used forocclusion of a left atrial appendage. In various embodiments, theexemplary devices described herein may be used for the occlusion of aleft ventricle, atrial septal wall, patent foramen ovale, etc.

Exemplary Device Use Case

FIGS. 9-12 depict an exemplary device use case. In particular, FIGS.9-12 depict an exemplary device as used within a left atrial appendage(LAA) within a patient's heart. Exemplary devices described herein maybe used in to occlude the LAA to, for example, help prevent a stroke inthe patient. Due to a high prevalence of thrombus forming in the LAA ofatrial fibrillation (AF) patients, occluding the LAA may prevent amajority of thrombus formation and thus reduces the risk of ischemicstroke.

A left atrial appendage closure (LAAC) procedure for a particularpatient is briefly described. This exemplary procedure is included tofurther promote an understanding of the exemplary devices and processesdisclosed herein and is not necessarily intended to be limiting. Theexemplary LAAC procedure for the particular patient may be done underlocal or general anesthesia in a catheterization lab using standardtransseptal techniques. The exemplary procedure may last about one hourand the patient will stay overnight at a hospital post implantation inorder to monitor any adverse effects.

Continuing with this exemplary procedure, a transesophagealechocardiogram (TEE) is performed to measure the LAA to determineocclusion size. In this exemplary procedure, after directing the accesssheath from the right femoral vein, a transseptal puncture will occur toallow for the access sheath to be placed into the left atrium. An accesssheath, in this exemplary procedure, will then be carefully placed intothe proximal portion of the LAA over a catheter. Continuing with thisexemplary procedure, an occlusion device is prepped by connecting to thedelivery system, inserted into the access sheath, and finally, directedto the target left atrial appendage under conventional imagingtechniques, including TEE and fluoroscopic guidance (fluoro). In thisexemplary procedure, the occlusion device is then deployed into the LAA,and positioning and occlusion is confirmed via imaging.

Turning now to FIG. 9, this figure depicts a patient's heart 300 and apartially inflated exemplary occlusion device 410 within the patient'sLAA 500. As will be understood from the discussion herein, the occlusiondevice 410, in one or more embodiments, is attached to the catheterdelivery system and travels through the access sheath. In particularembodiments, upon confirmation of position at the LAA from TEE andfluoro, the device 410 is inflated by inserting fluid using an injectionapparatus. According to various embodiments, the fluid used in thepresent method should be of low viscosity to allow for ease oftransportation through the delivery system but create enough pressureinside the occlusion device to allow for expansion and rigidity (e.g.,saline, sterile water, contrast, polymerizing agents, and varioushydrogels). In various embodiments, partial inflation occurs when capchamber 440 has been inflated while bulb chamber 460 remains uninflated.In some embodiments, partial inflation occurs when bulb chamber 460 isinflated while cap chamber 440 remains uninflated.

In at least one embodiment, the connection system 420 includes the pointof attachment and contact between the delivery system and the occlusiondevice 410 along with the area to facilitate fluid insertion. In oneembodiment, an injection apparatus is inserted inside the connectionsystem 420 to inflate the occlusion device 410. In the embodiment shownin FIG. 9, the cap chamber 440 has been inflated to fit the LAA 500opening anatomy and acts as a barrier to blood flow from the left atrium(LA) 300. In this embodiment, the uninflated bulb chamber 460 is void ofinner material or fluid.

FIG. 10 depicts a partial cross-sectional view of the exemplarypartially inflated device 400 as shown in FIG. 9. In variousembodiments, the connection system 420 contains an attachment method422, which is configured to attach the device 410 to the delivery systemand to support transportation and positioning of the device 410 to theLAA. In particular embodiments, a fluid passage body 430 is opened by aninjection apparatus and provides a pathway for the apparatus to travelto the cap chamber 440 or bulb chamber 460. In at least one embodiment,fluid passage channels 424 of the cap chamber 440 are configured toenable fluid to travel from the connection system 420 to the outer capfluid ring 444 to provide outward expansion of the cap chamber 440.According to particular embodiments, a fluid ring 444 is surrounded by acap body 442 to provide rigidity and reduced expansion towards the LA.In some embodiments, valves 426, 428, operatively fastened throughmethods such as, but not limited to, adhesives, molding, welding, andetc. At the proximal and distal end of an inner fluid passage channel432, respectively, are configured to control backflow of fluid and toseparate the second internal chamber 466 from the internal bulb chamber464. In one or more embodiments, an inner fluid passage channel opening434 allows fluid to calculatedly expand the bulb chamber 460 to allow anexemplary device 410 to adapt to a surrounding left atrial appendageanatomy and provide full occlusion. According to at least oneembodiment, the bulb chamber 460 includes a bulb exterior 462, which mayinclude combinations of texturing, ridges, coatings, and surfacemodification to improve compliance, adhesion to the LAA, and tissuegrowth. In particular embodiments, as the injection apparatus continuesto inflate the device, the bulb chamber 460 increases with fluid,causing a pressure to outwardly expand until an exemplary device 410adapts to a surrounding left atrial appendage anatomy and provides fullocclusion of the LAA body.

Turning now to FIG. 11, this figure depicts a patient's heart 300 and amore fully inflated exemplary occlusion device 410 within the patient'sLAA 500. As will be understood from the discussion herein, the occlusiondevice 410 is inflated fully to adapt to the LAA anatomy 500 and occludethe LAA 500 such that LAA 500 is blocked from the blood flow of the LA300.

According to one or more embodiments, upon confirmation that fullyinflated device 410 is inflated to fully adapt to the LAA 500, theconnection system 420 is configured to enable removal of the injectionapparatus from the device 410, which remains in the LAA 500. In at leastone embodiment, the connection system 420 is also the area of disconnectbetween the delivery system and the device 410. In some embodiments, thedelivery system and the access sheath then travel out of the heart 300and exit the right femoral vein. In various embodiments, the cap chamber440 assumes the anatomy of the orifice of the LAA 500, and the bulbchamber 460 assumes the anatomy of the body of the LAA 500.

FIG. 12 depicts a partial cross-sectional view of the partially inflateddevice 410 as shown in FIG. 11. In particular embodiments, uponconfirmation of the device being fully inflated (as discussed above),the connection system 420 begins to close as the injection apparatus isremoved from the fluid transport channel 430. In one or moreembodiments, the attachment method 422 is configured for detachmentbetween the device 410 and the delivery system. In at least oneembodiment, the fluid passage channels 424 are filled with a fluid tomaintain expansion and rigidity of the cap chamber 440. In manyembodiments, the cap body 442 maintains the structure and rigidity ofthe cap chamber 440. In particular embodiments, the outer cap fluid ring444 is filled with fluid and maintains the interaction between the edgesof the device 410 and the LAA orifice. According to at least oneembodiment, the valves 426, 428 close once the injection apparatus isremoved and prevent fluid movement among chambers 440, 460, 466. Inparticular embodiments, with a fully inflated bulb chamber 460, theinner bulb chamber 464 is filled with a fluid 468 to maintain shape andallows the bulb exterior 462 to interact with the LAA.

Alternate Embodiments

Alternate Structures

In a first alternate embodiment, an exemplary device may include aballoon that expands through mechanical supports. In this firstalternate embodiment, a nitinol or shape memory structure can beinserted inside a balloon, and after the device exits the deliverysystem, the structure expands to a particular morphology.

Various embodiments of the device herein are depicted as an acorn-shapedbody, but the device may be in suitable alternate shapes, includingcylindrical, bell-shaped, and ovular.

In some embodiments, an exemplary device may include features to furtherreduce dislodgement of the device from an LAA. In these embodiments,retention members may be attached to the balloon and may be hooks orcoils made of nitinol, alloys, various grades of steel, or differentshape-memory materials.

In particular embodiment, the bulb chamber exterior of the device (asdiscussed herein) may include various coatings or fabrics to promotehealing, tissue growth, antithrombogenicity, microbial stability, andadhesion. In this particular embodiment, suitable fabrics may include,but are not limited to ePTFE, PET, and Dacron. Continuing with thisparticular embodiment, appropriate coatings may include or be fromfibronectin, gelatin, fibrinogen, collagen IV, VEGF, polyurethane,fluorosilicone, Bactroban®, Cloramex®, Flamazine®, Fucidin®, Naseptin®,Terramycin®, hyaluronic acid, fibroblast growth factor, and heparin. Anadhesive, sealant, glue, or hydrogel could also be added to the deviceexterior to promote adhesion.

Various embodiments, of the internal portion of the device may includealternate constructions. In some embodiments, the device may beconstructed with one or more chambers. In one embodiment, a devicedesign is depicted with two bulb chambers. In some embodiments, onechamber may be made as only one bulb chamber inflation state is neededto fully inflate the balloon. In at least one embodiment, if multiple,separate chambers are constructed, multiple valves and inflation statesmay be used to control full inflation. In addition, in particularembodiments, the balloon may not feature multiple inner chambers or mayexhibit multiple inner chambers. In these particular embodiments, nosecondary inner chambers may reduce the number of valves as well asinternal structures to separate layers of the balloon. Alternatively, inembodiments with more than one inner chamber, various layers of theballoon may be constructed of alternating elastomeric materials or allowfor multiple inflation methods within one device chamber. In one or moreembodiments, multiple lumens may require increased number of valves. Inaddition, more than one connection system can be built to connect adelivery system to multiple chambers separately.

In particular embodiments, the cap body and thicknesses of the balloonmay modify shape and internal features of the balloon. In someembodiments, the cap body may be removed or vary in morphology otherthan in the embodiments shown in the figures and described above. In oneembodiment, passage channels may not be constructed, and the inner capchamber may be constructed as a void. According to particularembodiments, varying thickness of the cap may alter the shape of the capchamber and varying thicknesses of the bulb chamber may also be createdto alter inflation morphology or direct fluid transport.

Some embodiments may include varied valve placement. In theseembodiments (and others), one or more valves may be located at theproximal end of the connection system and may be configured to interfacewith the exterior of the device and the cap chamber. According toparticular embodiments, the exemplary device may include one or morevalves located within the passage channels. In some embodiments, theexemplary device may include additional valves defined by the openingsof lumens. In at least one embodiment, multiple chambers may beconnected with no valves to provide a more open connection system forfluid to travel between chambers. Such valves may include check valves,duckbill valves, and relief valves.

Alternate Use Cases

In particular embodiments, the balloon may be configured to be inflatedat various states, whether the cap chamber is inflated in the first orlast state. In some embodiments, the distal portion of the injectionapparatus may be located in the cap chamber as an initial step, allowingfor the cap chamber to be inflated first. Continuing with thisembodiment, the apparatus can then be pushed toward the bulb portion,allowing for a consecutive inflation state. The injection apparatus, inthis embodiment, can then be removed. In alternate embodiments, theinjection apparatus can be placed in the bulb chamber initially, and theapparatus is removed after the cap chamber is fully inflated.

As will be understood by one of ordinary skill in the art, the deviceand delivery system may also be delivered to the LAA from a differentmechanism than from the right femoral vein. In various embodiments, acatheter can also be used from the axillary, brachial, or radialarteries as well as the lumbar aorta to deliver the device to the LAA.In these embodiments, the operator must be familiar with thesealternative percutaneous routes, and these alternatives may limit sizingof the delivery system.

The device can be used for general soft tissue closure due tocustomizability, in some embodiments. In particular embodiments,customizability is provided by allowing control of inflation and sizingof the device, and the material properties allow for conformability withsurrounding structures. In various embodiments, softer material used inthe construction of the device may reduce risks such as tearing andperforation of the LAA or other tissue or organs. In some embodiments,these characteristics may be appropriate for closure of atrial septaldefects (ASDs) and patent foramen ovales (PFOs), which are defects foundin the atrial septal wall. As further discussed above, although thedevice is depicted with an acorn-shaped body, in particular embodiments,the device can assume a more dumbbell shape to occlude ASDs and PFOB.

CONCLUSION

Accordingly, the reader will see that devices described herein may beused to close off an appendage or any soft tissue defect or hole, becustomizable by conforming to the size and shape of the appendage,defect, or hole, easily retrievable by removing one or more fluids,reduce tearing and perforation due to the soft polymeric material, andsecurely attach to the appendage, defect, or hole due to its uniquetextured pattern.

The foregoing description of the exemplary embodiments has beenpresented only for the purposes of illustration and description and isnot intended to be exhaustive or to limit the embodiments discussedherein to the precise forms disclosed. Many modifications and variationsare possible in light of the above teaching.

The embodiments were chosen and described in order to explain theprinciples of the present disclosure and their practical application soas to enable others skilled in the art to utilize the present disclosureand various embodiments and with various modifications as are suited tothe particular use contemplated. Alternative embodiments will becomeapparent to those skilled in the art to which the present disclosurepertains without departing from their spirit and scope.

We claim:
 1. A method for occluding a left atrial appendage, the methodcomprising: passing a balloon system through a catheter system, theballoon system comprising a first chamber and a second chamber;inflating the balloon system using a connection system that fluidlyconnects the first chamber and the second chamber via at least onevalve, wherein inflating the balloon system comprises: inflating thefirst chamber in a lateral direction such that the first chambersubstantially fills a first portion of a left atrial appendage of apatient; and inflating the second chamber such that the second chambersubstantially fills a second portion of the left atrial appendage of thepatient.
 2. The method of claim 1, wherein: the first chamber and thesecond chamber are separated by an elastomeric wall; the connectionsystem a) extends through the first chamber and at least partiallythough the second chamber, b) is configured for delivering one or morefluids to the first chamber and the second chamber, and c) includes oneor more valves; the first chamber is configured to expand outwardly in alateral direction from a center of the first chamber to substantiallyfill a first portion of the left atrial appendage; and the secondchamber is configured to expand outwardly to substantially fill a secondportion of the left atrial appendage.
 3. The method of claim 1, whereinthe balloon system comprises a single polymer structure.
 4. The methodof claim 3, wherein the single polymer structure comprises a non-porousexterior surface for preventing permeation.
 5. The method of claim 1,wherein the connection system comprises: a first valve located in thefirst chamber for preventing fluid from traveling from the first chamberto an exterior of the device; and a second valve located in the secondchamber.
 6. The method of claim 5, wherein the connection system furthercomprises a channel for transporting fluid to the first chamber and thesecond chamber.
 7. The method of claim 6, wherein the channel a) definesone or more openings for transporting fluid to the first chamber, and b)terminates at the second valve.
 8. The method of claim 1, wherein thesecond chamber comprises an exterior for adhesion to a biologicalstructure.
 9. The method of claim 8, wherein the exterior of the secondchamber comprises a coating for promoting tissue growth within thebiological structure.
 10. The method of claim 8, wherein the exterior ofthe second chamber comprises an irregular texture for adhesion to thebiological structure.
 11. The method of claim 1, wherein the secondchamber comprises an exterior for adhesion to the left atrial appendage.12. The method of claim 11, wherein the exterior of the second chambercomprises a coating for promoting tissue growth within the left atrialappendage.
 13. The method of claim 11, wherein the exterior of thesecond chamber comprises an irregular texture for adhesion to the leftatrial appendage.
 14. The method of claim 1, wherein the first chambercomprises an exterior for adhesion to a biological structure.
 15. Themethod of claim 14, wherein the exterior of the first chamber comprisesa coating for promoting tissue growth within the biological structure.16. The method of claim 14, wherein the exterior of the first chambercomprises an irregular texture for adhesion to the biological structure.17. The method of claim 1, wherein the first chamber comprises anexterior for adhesion to the left atrial appendage.
 18. The method ofclaim 17, wherein the exterior of the first chamber comprises a coatingfor promoting tissue growth within the left atrial appendage.
 19. Themethod of claim 17, wherein the exterior of the first chamber comprisesan irregular texture for adhesion to the left atrial appendage.